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FDA 510(k)

SpO2 Sensor

K-Number: K183277 · 2019-05-15

ApplicantShenzhen Upnmed Equipment Co., Ltd.
Decision Date2019-05-15
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SpO2 Sensor is a medical device manufactured by Shenzhen Upnmed Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-05-15 under approval number K183277. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpO2 Sensor?

SpO2 Sensor is a medical device that received FDA 510(k) clearance on 2019-05-15. It is manufactured by Shenzhen Upnmed Equipment Co., Ltd.. The 510(k) number is K183277.

When was SpO2 Sensor approved by the FDA?

SpO2 Sensor received FDA 510(k) clearance on 2019-05-15, under approval number K183277.

What company makes SpO2 Sensor?

SpO2 Sensor is manufactured by Shenzhen Upnmed Equipment Co., Ltd..

What is the FDA product code for SpO2 Sensor?

The FDA product code for SpO2 Sensor is DQA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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